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Arcutis' Roflumilast Cream For Psoriasis Goes Under FDA Review

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Arcutis' Roflumilast Cream For Psoriasis Goes Under FDA Review

The FDA has accepted Arcutis Biotherapeutics Inc's (NASDAQ: ARQT) marketing application seeking approval for roflumilast cream for psoriasis in adults and adolescents. 

  • The FDA assigned the application a Prescription Drug User Fee Act target action date of July 29, 2022.
  • Roflumilast cream (ARQ-151) is a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that drives overactive immune responses. 
  • Related: Arcutis Stops ARQ-252 Vitiligo Trial After Formulation-Related Observations In Chronic Hand Eczema Study.
  • Arcutis' NDA submission is supported by data from Arcutis' pivotal Phase 3 program and a long-term Phase 2b open-label study. DERMIS 1 and DERMIS 2 Phase 3 studies evaluated the safety and efficacy of roflumilast cream 0.3%. 
  • Roflumilast met its primary endpoint and had an Investigator Global Assessment (IGA) success rate of 42.4% compared to a vehicle rate of 6.1% and 37.5% compared to a vehicle rate of 6.9%, in DERMIS 1 and 2, respectively. 
  • Price Action: ARQT shares closed at $18.54 on Wednesday.
 

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Posted-In: Briefs PsoriasisBiotech News Health Care Small Cap FDA General

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